Category: Scientific & Clinical
Job Title: Senior Clinical Research Associate/Clinical Research Associate II
Employment: Direct Fulltime
Location: West Coast Regional Travel
Start Date: Immediate
- Study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing and communicating the status of study progress and activities
- Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.
- Provide coaching and training to junior employees
- Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
- Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve efficiencies within and across related functional areas
- Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations
- Prepare materials for steering and investigator meetings
- Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
- Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
- Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
- Manage monitoring progress of contract & CRO CRAs for respective sites.
- Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
- Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
- Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
- Validate investigational device accountability by tracking the history of investigational devices to the field sites and through final disposition.
- Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
- Edit/amend informed consent documents.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
- Bachelor's Degree in related field with 4 years of previous field monitoring experience required
- Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
- Demonstrated problem-solving and critical thinking skills
- Proven expertise in MS Office Suite, including Word, Excel, Adobe
- Experience working in a medical device or regulated industry preferred
- Experience with electronic data capture preferred
- Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification) preferred
- Ability to travel up to 65% required